On July 12, 2022, at the site of the Single Distributor, a discussion meeting was held with the National Center for Expertise of Medicines and Medical Devices RSE on PVC on the quality and safety of medicines within the framework of the guaranteed volume of free medical care and in the compulsory health insurance system.
This meeting was organized to solve the existing problems and improve the provision of the population with high-quality medicines and medical devices. The Single Distributor and the National Center for Expertise are working together to improve the drug supply system, considering the announced proposals of the business communities.
The meeting was attended by the General Director – Chairman of the Board Dauytbayev Yerken and the Head of the Department for Harmonization of Legislation and Strategy Daulet Sabdenaliyev from the side of the National Center of Expertise.
First, the terms of registration of medicines and medical devices were discussed, which affect the terms of execution of long-term contracts with domestic manufacturers. Agreements were reached between the Single Distributor and the National Center for Expertise on the need to create a system for comparing data on registration of medicines and medical devices by domestic manufacturers under existing long-term contracts.
Another important issue discussed by the parties was so called the yellow cards system. Kazakhstan has introduced a system for monitoring, analyzing and evaluating information on the safety of registered medicines. If an adverse reaction or its ineffectiveness in the treatment of a disease is detected, patients should contact their doctor to fill out a yellow card-message on the website of the Center for Expertisehttps://www.ndda.kz/.
All received cards are subject to careful analysis. All factors that caused a serious adverse reaction are checked, drug samples are withdrawn and laboratory tests are carried out. Based on the results of the examination, the regulatory authority decides to suspend the series or the entire registration certificate of the medicinal product. Monitoring covers all regions and is carried out in accordance with international standards.
The yellow cards system practice is primarily for the safety of patients. It is precisely such feedback tools that contribute to the formation of a patient-oriented healthcare system.
The Single Distributor prioritizes the quality and safety of medicines provided to Kazakhstani medical institutions by increasing the requirements for suppliers, including using such feedback tools as yellow cards.
Thus, according to the National Center for Expertise, in 2020, 356 cases were detected in 9 domestic manufacturers, and in 2021, 385 cases were detected in 5 domestic drug manufacturers.
In addition, questions were raised on making changes to long-term contracts with domestic manufacturers upon receipt of a registration certificate. It is noted that after receiving the registration certificate, the characteristics of medical devices, in accordance with the received registration certificate, do not correspond to the characteristics specified in long-term contracts.
The parties also discussed the formation of a nomenclature of medicines and medical devices for holding tenders for concluding long-term supply contracts. According to the Rules for organizing and conducting procurement No. 375, the nomenclature does not include medicines and medical devices registered by domestic manufacturers, as well as for which there is a concluded long-term supply contract.
In turn, the Single Distributor announced a number of its proposals. Namely: providing a monthly summary of applications submitted for registration of medicines and medical devices from domestic manufacturers with current statuses and accelerating registration processes.
It is also proposed to fully automate the process of filling and sending message cards for effective quality control of medicines and taking appropriate measures, to work out a mechanism for amending long-term contracts in terms of characteristics for medical devices and determine the structural unit responsible for the analysis of the nomenclature to avoid duplication of positions in long-term contracts.
In Kazakhstan, the issues of public health, safety, as well as the quality and effectiveness of medicines are given special attention and are attributed to the factors of ensuring national security. Issues with the circulation of medicines are regulated by the Code of the Republic of Kazakhstan “On the health of the people and the healthcare system”. The quality and safety of pharmaceutical products are of paramount importance for the Single Distributor in the procurement and distribution of medicines. A comprehensive and multi-stage system of state supervision over the circulation of medicines contributes to providing the population of Kazakhstan with safe, effective and high-quality medicines.
Reference:
Yellow Card is a message about the side effects of the drug, about the identified cases of side effects in the medical use of the drug and includes a list of questions that allow for an approximate determination of the degree of causal relationship between taking the drug and its side effects. The yellow card method is a regional or national system for reporting suspected adverse drug reactions and is the primary pharmacovigilance method (WHO).
NCEMP is a state expert organization in the field of circulation of medicines and medical devices.
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